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Sponsors and Collaborators: |
Trans-Tasman Radiation Oncology Group (TROG) Cancer Council New South Wales |
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Information provided by: | Trans-Tasman Radiation Oncology Group (TROG) |
ClinicalTrials.gov Identifier: | NCT00193869 |
The study aimed to pilot the viability of a full scale randomised comparison of 2 steroid doses in malignant spinal cord compression, to establish safety of high dose dexamethasone in this setting in Australia, to test web registration and randomisation and to compare different functional outcome measures.
Condition | Intervention | Phase |
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Spinal Cord Compression From Neoplasm Metastasis |
Drug: Dexamethasone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Randomised Comparison of Dexamethasone 96 mg Versus 16 mg Per Day for Malignant Spinal Cord Compression Treated by Radiotherapy |
Enrollment: | 20 |
Study Start Date: | September 2001 |
Study Completion Date: | December 2003 |
Malignant spinal cord compression (MSCC) is an uncommon condition with an estimated annual incidence of 2.5 per 100,000. It is a dreaded complication of malignancy because of the severe impact paralysis and sphincter disturbance has on quality and duration of survival.
Rat models have demonstrated the effectiveness of high doses of steroids. Only three randomised controlled trials (RCTs) have been published. The first compared radiotherapy to laminectomy plus radiotherapy in a series of 29 patients and failed to show any significant differences The widespread commonly used dose of Dexamethasone in Australia at that time was 16 mg/24 hr and the main concern for implementing higher doses was the toxicity profile reported in the few small randomised comparisons available at the time.In view of the conflict between standard Australian practice versus published (overseas) guidelines, a randomised comparison was proposed in Australia. This study was a pilot study initiated to determine the viability of a large trial, to pilot the use of web technology for trial conduct and to determine clinically useful outcome measures apart from simple ambulation rates. Comparisons: Patients randomised to receive either 16mg/24hr or 96mg/24hr dexamethasone.
Ages Eligible for Study: | 17 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Australia, New South Wales | |
St George Hospital | |
Kogarah, New South Wales, Australia, 2217 |
Study Chair: | Peter Graham, FRANZCR | St George Hospital |
Study ID Numbers: | TROG 01.05 |
Study First Received: | September 11, 2005 |
Last Updated: | May 8, 2007 |
ClinicalTrials.gov Identifier: | NCT00193869 History of Changes |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Radiotherapy Dose fractionation |
Anti-Inflammatory Agents Dexamethasone Antineoplastic Agents, Hormonal Spinal Cord Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin |
Antiemetics Glucocorticoids Hormones Spinal Cord Injuries Spinal Cord Compression Neoplasm Metastasis Peripheral Nervous System Agents Dexamethasone acetate |
Anti-Inflammatory Agents Dexamethasone Spinal Cord Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Disorders of Environmental Origin Antiemetics Hormones Spinal Cord Injuries Neoplastic Processes Pathologic Processes Spinal Cord Compression Therapeutic Uses |
Neoplasm Metastasis Dexamethasone acetate Antineoplastic Agents, Hormonal Nervous System Diseases Wounds and Injuries Gastrointestinal Agents Central Nervous System Diseases Glucocorticoids Pharmacologic Actions Neoplasms Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents |